The development of modern endoscopic instrumentation has significantly affected the manner in which many surgical procedures are performed. Indeed, many procedures which have traditionally required large surgical incisions (e.g. laparotomy) may now be performed endoscopically, by inserting an endoscopic viewing device (e.g. a laparoscope, arthroscope, bronchoscope, etc.) along with various surgical instruments through natural body openings or small incisions.
The development of modern endoscopic surgical procedures has enabled surgeons to perform major operative procedures at relatively low risk, without the need for deep muscle relaxation and with minimal blood loss and minimal post-operative discomfort.
In particular, recent advancements in laparoscopic technology have enabled surgeons to perform various intra-abdominal surgical procedures through one or more relatively small (e.g. 1 cm) laparoscopy incisions rather than through the traditional, relatively large (e.g. 5-20 cm) laparotomy incision.
In accordance with standard laparoscopic technique, an inflation needle is initially inserted into the peritoneum and carbon dioxide is passed therein to create a distended pneumoperitoneum. Thereafter, a small periumbilical incision is formed and a primary portal or trocar is inserted through such periumbilical incision into the distended peritoneum. The laparoscope is then inserted into the peritoneum through the primary umbilical trocar. One or more secondary trocars or accessory portals may also be inserted through one or more secondary incisions or puncture wounds formed in the abdominal wall. Such secondary trocars or accessory portals are generally used for passage of blunt forceps, cannulas and other instruments into the abdomen.
After such instruments have been inserted through the accessory portals, the instruments are used to carry out the desired surgical excision and/or manipulation of organs and tissues within the abdomen while the surgeon views the operative site through the previously inserted laparoscope. Any surgically excised tissue or other material which is to be removed during the surgical procedure must then be extricated from the body, preferably by extraction through one of the previously made laparoscopy portal incisions.
For example, a common hernia repair may be effected endoscopically by suturing a fabric mesh in place over the wound to provide support to the weakened area during the healing process. This is typically accomplished by using forceps or other surgical tools to manipulate a threaded needle through a trocar in order to form the sutures. The suturing process commonly is simultaneously observed through an endoscope inserted through a separate trocar. To accomplish suturing, the threaded needle must be passed through the trocar and into the inflated abdomen or pneumoperitoneum; the sutures must be formed; a knot must be tied and the thread cut when suturing is complete; and finally the needle and remaining thread must be extracted through the trocar.
Although laparoscopic procedures have evolved to the point when internal incisions and the like may be repaired by manipulating a threaded needle endoscopically to form sutures, the ultimate success and feasibility of many such surgical procedures is dependent upon the ability of the surgeon to perform the procedure in a limited amount of time. Manual endoscopic suturing is a time-consuming task requiring a great deal of skill.
Similar problems exist in suturing anatomical body portions and/or therapeutic devices, e.g. a fabric mesh, in other contemporary surgical procedures, including those which are performed through natural body openings such as the oral cavity, urethra, vagina, rectum, etc.
Laparoscopy has, for some time, been used in the treatment of gynecologic diseases. More recently, and largely due to the development of highly efficient laser cutting and coagulation devices, laparoscopy has shown promise as a modality for performing various other general surgical procedures which had heretofore been performed through relatively large (e.g. 5-40 cm) laparotomy incisions. Indeed, frequently performed intra-abdominal surgical procedures such as cholecystectomy and appendectomy may now be approached with the laparoscope through a relatively small (e.g. 1 cm) abdominal puncture. The feasibility of performing such operations is, however, in part dependent upon the ability of the surgeon to close wounds, suture therapeutic devices in place, and suture anatomical body portions in place.
Any endoscopic suturing or stapling must take place through a trocar inserted into one of the previously made laparoscopy portal incisions. Thus contemporary surgical staplers cannot be substituted for suturing since they cannot be inserted through the opening of a trocar.
Prior art surgical staples generally suffer from the deficiency that, after stapling, they are undesirably prone to being pulled out of the anatomical body portion and/or therapeutic device into which they have been disposed. Such prior art surgical staples have straight arms which are not crimped toward each other. Thus, such prior art staples lack a mechanism to prevent their moving away from and out of engagement with the anatomical body portion and/or therapeutic device into which they have been inserted. Movement of the stapled anatomical body portions and/or therapeutic devices, as well as tension placed thereupon, may cause such prior art staples to be pulled out.
In view of the problems associated with endoscopic suturing and similar surgical procedures, i.e. stapling, there exists in the art the need for an improved staple which is not substantially subject to being inadvertently pulled out and for an instrument which may be passed into the pneumoperitoneum or the like through a standard (e.g. 1 cm) laparoscopy incision to effect stapling of anatomical body portions and/or therapeutic devices.